EP2319454B1 - Dispositif de pontage pour influencer la pression sanguine - Google Patents

Dispositif de pontage pour influencer la pression sanguine Download PDF

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Publication number
EP2319454B1
EP2319454B1 EP10014333.8A EP10014333A EP2319454B1 EP 2319454 B1 EP2319454 B1 EP 2319454B1 EP 10014333 A EP10014333 A EP 10014333A EP 2319454 B1 EP2319454 B1 EP 2319454B1
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EP
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Prior art keywords
pressure
volume
mmhg
implant
pressure threshold
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EP10014333.8A
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German (de)
English (en)
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EP2319454A1 (fr
Inventor
Mirko Dr. Doss
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Es Bio-Tech Ltd
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Es Bio-Tech Ltd
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Priority to SI201030555T priority Critical patent/SI2319454T1/sl
Priority to PL10014333T priority patent/PL2319454T3/pl
Publication of EP2319454A1 publication Critical patent/EP2319454A1/fr
Application granted granted Critical
Publication of EP2319454B1 publication Critical patent/EP2319454B1/fr
Priority to CY20141100218T priority patent/CY1114982T1/el
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/152—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel branching on and drawing blood from a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
    • A61M60/837—Aspects of flexible displacement members, e.g. shapes or materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/871—Energy supply devices; Converters therefor
    • A61M60/882—Devices powered by the patient, e.g. skeletal muscle powered devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30069—Properties of materials and coating materials elastomeric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30074—Properties of materials and coating materials stretchable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30548—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A61F2250/0002—Means for transferring electromagnetic energy to implants for data transfer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0013—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting fluid pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • the invention relates to a bypass device for influencing the blood pressure, which comprises an implant with a volume chamber.
  • the implant has connection means for connecting the volume chamber to a natural cardiovascular system and adaptive means that enable or effect a volume change of a volume of the volume chamber upon a pressure change in the cardiovascular or volume chamber.
  • the DE 10 2004 018 255 A1 discloses an implant in the form of a vascular prosthesis, which is formed substantially as a tube with an elastic inner wall.
  • a vascular prosthesis By a nonwoven structure, the elasticity of the elastic inner wall is limited, whereby a pressure-expansion behavior is achieved, which corresponds essentially to the extensibility of natural arteries at systolic pressure and diastolic pressure.
  • the vascular prosthesis can restore or assist the so-called windkessel effect of the natural arteries, and especially the aorta.
  • the function of the vesicle is the retention of part of the blood volume expelled from the heart during systole in the elastic central arteries and its continuous delivery during diastole.
  • the Windkessel function causes a homogenization of the arterial blood flow in the circulatory periphery.
  • a diminished or Disturbed air vessel function of natural arteries means a fundamentally higher work for the heart, whereby the risk of heart damage increases in the long term.
  • Due to the elastic inner wall of the vascular prosthesis DE 10 2004 018 255 A1 By stretching the inner wall during systole (ejection phase of the heart), a larger amount of blood is briefly stored. During diastole (relaxation of the heart muscle), the temporary vascular prosthesis stored blood is pushed out of the vascular prosthesis due to the elasticity of the inner wall.
  • an implant is known as a replacement of a portion of the aorta or an artery whose volume is formed elastically deformable by a spring incorporated into the vessel wall. This implant also supports the windkessel effect.
  • the US 2007/0287879 A1 a spring device which is inserted into a blood vessel.
  • the treated blood vessel is initially deformed elliptical, whereby its volume is reduced.
  • the blood pressure then returns the blood vessel to normal size, which lowers blood pressure.
  • WO 89/01765 A1 is a prosthetic device for increasing the compliance of arteries.
  • the device includes a balloon-like implant that exhibits a blood pressure-dependent volume change.
  • the US 2004/0143319 A1 shows an implant for lowering high blood pressure, which can be implanted in parallel to a natural blood vessel.
  • the device is provided with a volume chamber which is connected in parallel to a portion of a natural blood vessel and is connected thereto in such a way that the volume chamber is arranged outside the blood vessel.
  • the volume chamber is limited by an elastic material, which changes its volume as pressure changes in the volume chamber.
  • the invention is therefore based on the object to provide a device for influencing the blood pressure, in particular by the Hypertension can be treated effectively and as much as possible without the need for medication.
  • the device for influencing the blood pressure according to claim 1, in particular a bypass device is characterized in that a volume change of a volume of the volume chamber in a lower pressure range between 50 mmHg and at least 120 mmHg pressure threshold not more than 3 cm 3 and in an upper Pressure range between the pressure threshold and 150 mmHg is at least 25 cm 3 .
  • the volume change in the lower pressure range is to be understood as meaning that with a pressure increase of 50 mmHg to the pressure threshold value of 100 mmHg, the volume of the volume chamber increases by at most 3 cm 3 . Accordingly, the volume of the volume chamber in the upper pressure range should increase at least by 25 cm 3 at a pressure increase of 100 mmHg to 150 mmHg.
  • This situation can preferably be further specified by the ratio of differential volume change to differential pressure change, which corresponds to the slope of a curve in a Vp diagram.
  • the differential volume change per differential pressure change for pressure values in a lower pressure range between 50 mmHg and at least 100 mmHg pressure threshold can not exceed 0.2 cm 3 / mmHg and in an upper pressure range between the pressure threshold and 150 mmHg at least 0.2 cm 3 / mmHg amount.
  • a bypass device for influencing blood pressure comprising an implant having a volume chamber, connection means for connecting the volume chamber to a natural cardiovascular system, and adapting means by which a volume change of a volume of the volume chamber occurs one Pressure change in the cardiovascular system or in the volume chamber is enabled or effected, wherein the differential volume change per differential pressure change for pressure values in a lower pressure range between 50 mmHg and at least 100 mmHg pressure threshold not more than 0.2 cm 3 / mmHg and in an upper pressure range between the pressure threshold and 150 mmHg is at least 0.2 cm 3 / mmHg.
  • the pressure threshold is at least 120 mmHg. Good values for the treatment of high blood pressure can also be achieved if the pressure threshold is above 130 mmHg or even 140 mmHg.
  • the upper or first value is called the systolic arterial pressure. It characterizes the pressure in the heart at the moment when the heart muscle contracts to the maximum. As soon as the heart muscle relaxes, the arterial pressure drops to the second or lower pressure (diastolic arterial pressure). Arterial hypertension is present when repeated measurements reach 140 mmHg for the first value and 90 mmHg for the second value.
  • bypass device which has a volume chamber whose volume changes only very slightly in the pressure range below the pressure threshold value (lower pressure range), but can change greatly in the pressure range above the pressure threshold value (upper pressure range), can be targeted arterial hypertension can be treated.
  • the bypass device according to the invention which is implanted parallel to a section of a natural blood vessel, thereby serves to artificially increase the volume of the natural cardiovascular system and thus forms a variable in size volume buffer, especially at high pressures in the system for a short time absorb a certain amount of blood and can deliver it again as the system pressure decreases.
  • the pressure threshold value can be below the systolic arterial pressure of 140 mmHg, which in the case of repeated measurement is based on arterial hypertension.
  • the volume change in the lower pressure range between 50 mmHg and the pressure threshold value is 3 cm 3 , so that virtually no change in volume takes place in the volume chamber of the implant in the lower pressure range.
  • the volume change is significantly higher than 10 cm 3 .
  • the lower limit is 25 cm 3 .
  • the ratio of the differential change in volume to change in pressure differential may be for pressure values in the lower pressure range between 50 mmHg and the pressure threshold value is at most 0.1 cm 3 / mmHg or even at most 0.06 cm 3 / mmHg.
  • the differential volume change per differential pressure change may be at least 0.3 cm 3 / mmHg, at least 0.4 cm 3 / mmHg or even at least 0.5 cm 3 / mmHg.
  • the adjustment means by which a volume change of the volume of the volume chamber is enabled or effected in the change of pressure in the cardiovascular system or in the volume chamber, may comprise an energy storage which receives energy upon a pressure increase and releases energy upon a pressure drop.
  • the adaptation means absorb energy, thereby avoiding an otherwise higher pressure rise. In diastole, a pressure drop can be observed, with the energy storage now giving off its energy and pushing blood out of the volume chamber, causing less pressure drop.
  • the energy store may comprise an elastic material which preferably at least partially limits the volume chamber. As the pressure increases, this elastic material expands to relax in the direction of its original shape when the pressure drops.
  • the energy storage may alternatively or additionally include spring devices that impose a certain geometric shape on the volume chamber, which changes as the pressure changes.
  • the implant could be in the form of a cylinder, with the spring devices compressing the cylindrical cross-section to an elliptical cross-section, with the result that the volume is correspondingly reduced.
  • a nearly cylindrical cross section is again achieved against the force of the spring devices, as a result of which the volume of the implant increases correspondingly.
  • the spring devices again press the implant into the shape with an elliptical cross section. The volume is reduced again.
  • the adjustment means may comprise mechanical and / or electrical components. It is also conceivable that the adaptation means comprise magnets, by means of which a volume change of the volume chamber can be influenced in a targeted manner.
  • the pressure threshold is adjustable.
  • the pressure threshold is from the outside adjustable.
  • the pressure threshold value could be set by way of suitable control of the implant from the outside in such a way that certain blood pressures of the patient are not exceeded. This allows the pressure threshold to be set individually for each patient. It is also conceivable that the pressure threshold value is set as a function of the expected load on the cardiovascular system. For example, compared to a very moderate load, another pressure threshold can be set for expected high loads.
  • the term “externally adjustable” thus means that the pressure threshold can be changed, even if the implant is already implanted. However, it is also possible that the pressure threshold value can be set directly before implantation via corresponding settings directly on the implant. Thus, an implant could be made, which can then be adjusted individually for different patients and needs before implantation.
  • the implant has a control with a sensor, by which a pressure in the cardiovascular system or in the volume chamber can be detected.
  • the control can preferably emit a signal upon reaching the pressure threshold value or a value correlating with the pressure threshold value, which value can be output to the adaptation means. For example, if the pressure detected by the sensor is below the pressure threshold value, the adjustment means have a different behavior with regard to the volume change than in the case where the detected pressure is above the pressure threshold value.
  • volume chamber Preferably, external protection against ingrowth and / or ingrowth of natural tissue into the volume chamber is provided. This can ensure that the volume chamber and also the adaptation means are protected from natural tissue or is not impaired by their functions.
  • the pressure threshold is externally adjustable, suitable means are required. These means may comprise a receiver which receives non-contact signals from a transmitter transmitting from the outside.
  • the device may also include a transmitter in order to be able to read, for example, measured values with regard to blood pressure, pulse rate, etc.
  • the exchange or the sending or receiving can be done by means of electromagnetic waves, for example by Radio Frequency Identification (RFID).
  • RFID Radio Frequency Identification
  • a reservoir may be provided which has a capacity of 100 ml to 1000 ml, preferably 500 ml to 750 ml.
  • the reservoir may be helical and / or spiral.
  • the blood volume accommodatable by the reservoir may be predeterminable and calibratable to individually adjust a desired amount of venous blood volume for each patient. This adjustment of the volume of intakes can be regulated from the outside and possibly at the doctor's request.
  • FIG. 1 shows a first embodiment of an inventive implant, which is designated in its entirety by 10.
  • the implant 10 comprises a biocompatible elastic tube 11, at the ends of which two rings 12a, 12b are fastened.
  • the rings 12a, 12b serve as suturing rings to allow attachment of the implant 10 in or on a cardiovascular system.
  • the implant 10 also has a biocompatible outer sheath 13, which is intended to prevent natural tissue from impairing the function of the elastic tube or tube 11.
  • the lines 14a, 14b and 14c are intended to represent different states of deformation of the tube 11 when there is a pressure in the tube which pushes the tube wall to the outside.
  • the deformation state 14c the highest pressure is applied while the deformation state 14a is the smallest pressure.
  • the pressure at the deformation state 14b is between the pressures of the deformation states 14a, 14c.
  • the deformed tube 11 also changes a volume V of a volume chamber 15, which is delimited by the tube wall of the tube 11.
  • the largest volume V c of the volume chamber 15 of the implant 10 thus results.
  • FIG. 2 shows the relationship between a blood pressure P in the volume chamber 15 and a volume change .DELTA.V of the volume of the volume chamber 15.
  • a pressure threshold P s are a lower Pressure range and an upper pressure range specified.
  • the lower pressure range is sufficient FIG. 2 from 50 mmHg to the pressure threshold P S
  • the upper pressure range extends from the pressure threshold P S to 150 mmHg.
  • the volume change ⁇ V O is substantially greater than the volume change ⁇ V U in the lower pressure range.
  • the pressure threshold P s is approximately 100 mmHg.
  • the pressure threshold Ps assumes other values, for example 120, 130, 140 mmHg. Since the volume change is very small up to the pressure threshold value P S , the influence of the implant 10 on the blood pressure of the patient is also small. Only from the pressure threshold value P S does a significantly greater volume change ⁇ V O occur , so that then the implant has a significant influence on the blood pressure of the patient. Thus, blood pressures above the pressure threshold value P S , in particular high blood pressure above 140 mmHg, can be influenced in a targeted manner, without the blood pressure being significantly influenced by the implant 10 at small blood pressures (smaller than the pressure threshold value P S ).
  • FIGS. 3 to 5 Further embodiments of the implant according to the invention are shown, wherein parts or features corresponding to the parts or features of FIG. 1 are similar or identical, be provided with the same reference numerals.
  • FIG. 3 also shows an implant 10 which is connected to an aorta 30 such that the implant 10 is connected in parallel with an upper portion 31 of the aorta.
  • dashed lines 16a, 16b is in FIG. 3 indicated that the volume of the volume chamber 15 of the implant 10 is also variable.
  • the implant 10 of the FIG. 3 has a suturing member 17 that replaces a part of the aorta 30.
  • a ring not shown here, to connect the end 18 of the implant with the aorta 30.
  • FIG. 4 shows an embodiment of the implant 10, also equipped with sewing rings 12a, 12b.
  • the implant 10 here has expandable hollow chambers 19, 20, which have a corresponding elasticity in order to influence the blood pressure in accordance with the invention.
  • serve lines 21a, 21b of the illustration which, upon appropriate pressurization of the implant 10, the hollow chamber 19, 20 expand and thus lead to a change in volume of the volume chamber 15 of the implant.
  • FIG. 5 (FIGS. 5a, 5b, 5c ) now shows further embodiments of the implant 10 according to the invention, wherein here not longitudinal sections, but schematically cross-sections of the implant 10 are shown.
  • the implant 10 has a substantially circular tube cross-section 22 which, however, has two inwardly directed indentations 23a, 23b.
  • a spring element 25 is arranged, which is pulled apart when the implant is pressurized.
  • the elasticity of the spring means 25 in conjunction with the geometry of the tube cross-section 22 is set so that only disappear from a certain pressure, the indentations completely and lead to an expansion of the cylindrical cross-section 22, so that the volume of the implant 10 increases significantly.
  • FIG. 5b has an inner shell 26 and an outer shell 27. Between the inner shell 26 and outer shell 27, two radially inwardly directed spring elements 28 are arranged, which create two radially inwardly projecting indentations or folds 29a, 29b.
  • FIG. 5c shows an externally patched bracket 30 through which a deformable tube 11 of the implant 10 is compressed at a portion of the circumference of the tube 11. As the pressure in the tube 11 increases, the ends 32a, 32b of the clip are pressed apart, resulting in an enlarged cross section of the tube 11 and thus a larger volume of the implant 10.
  • the spring elements 25, 28 and 30 in conjunction with the indentations 23a, 23b, 29a, 29b and folds 31 are designed so that a significant change in volume of the implant 10 is established only after reaching the pressure threshold value. As soon as the pressure threshold is reached, a completely new relationship between pressure change and volume change results.
  • FIG. 6 shows an embodiment of a venous reservoir 50 according to the invention.
  • the venous reservoir 16 can receive a certain amount of blood.
  • the venous reservoir 50 may, as in FIG. 6 shown inserted into the abdominal cavity in the femoral veins 61 of the patient 62.
  • the venous reservoir can in principle be used without the implant 10, which in preferred embodiments in the FIGS. 1 to 5 is described.
  • the venous reservoir is preferably less elastic and less expansible than the implant 10.
  • FIG. 6 shows a further embodiment of the venous reservoir.
  • the reservoir 50 of the FIG. 7 is inserted in the lung cavity 63.
  • the helical or spiral reservoir 50 serves to receive blood volume in the venous system between the superior vena cava 64 and the inferior vena cava 65 so that a particular volume of blood in the right atrium 66 may be displaced or held at a desired pressure level.
  • the reservoir 50 is wound around its own axis so as to minimize the external dimensions and to maximize the internal volume.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Vascular Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pulmonology (AREA)
  • Transplantation (AREA)
  • Medical Informatics (AREA)
  • Rheumatology (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
  • Surgical Instruments (AREA)

Claims (7)

  1. Dispositif de pontage pour influencer la pression sanguine dans un système cardiovasculaire, comprenant un implant (10) pourvu d'une chambre volumique (15), de moyens de liaison qui permettent de monter la chambre volumique (15) en parallèle à une partie d'un vaisseau sanguin naturel et de moyens d'adaptation par lesquels un changement d'un volume de la chambre volumique (15) est rendu possible ou effectué lors d'un changement de pression dans le système cardiovasculaire ou dans la chambre volumique, caractérisé en ce que le changement de volume
    - est d'au plus 3 cm3 dans une plage de pression inférieure entre 50 mmHg et une valeur seuil de pression d'au moins 120 mmHg, et
    - est d'au moins 25 cm3 dans une plage de pression supérieure entre la valeur seuil de pression et 150 mmHg.
  2. Dispositif de pontage selon la revendication 1, caractérisé en ce que la valeur seuil de pression est d'au moins 130 mmHg.
  3. Dispositif de pontage selon la revendication 2, caractérisé en ce que la valeur seuil de pression est d'au moins 140 mmHg.
  4. Dispositif de pontage selon une des revendications 1 à 3, caractérisé en ce que la valeur seuil de pression est réglable.
  5. Dispositif de pontage selon une des revendications 1 à 4, caractérisé en ce qu'il est prévu une commande avec un capteur par lequel une pression dans le système cardiovasculaire ou dans la chambre volumique (15) peut être déterminée.
  6. Dispositif de pontage selon la revendication 5, caractérisé en ce qu'un signal qui est destiné aux moyens servant à permettre le changement de volume peut être généré par la commande lorsque la valeur seuil de pression ou une valeur en corrélation avec la valeur seuil de pression est atteinte.
  7. Dispositif de pontage selon une des revendications 1 à 6, caractérisé par une protection extérieure (13) contre une croissance de tissu naturel dans et/ou sur la chambre volumique.
EP10014333.8A 2009-11-07 2010-11-05 Dispositif de pontage pour influencer la pression sanguine Active EP2319454B1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
SI201030555T SI2319454T1 (sl) 2009-11-07 2010-11-05 Premostitvena naprava za vplivanje na krvni tlak
PL10014333T PL2319454T3 (pl) 2009-11-07 2010-11-05 Urządzenie bajpasujące do wpływania na ciśnienie krwi
CY20141100218T CY1114982T1 (el) 2009-11-07 2014-03-20 Διαταξη παρακαμψης για τον επηρεασμο της πιεσης του αιματος

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102009052349A DE102009052349A1 (de) 2009-11-07 2009-11-07 Vorrichtung zur Beeinflussung des Blutdrucks

Publications (2)

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EP2319454A1 EP2319454A1 (fr) 2011-05-11
EP2319454B1 true EP2319454B1 (fr) 2014-01-01

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EP10014333.8A Active EP2319454B1 (fr) 2009-11-07 2010-11-05 Dispositif de pontage pour influencer la pression sanguine

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US (1) US8795221B2 (fr)
EP (1) EP2319454B1 (fr)
CY (1) CY1114982T1 (fr)
DE (1) DE102009052349A1 (fr)
DK (1) DK2319454T3 (fr)
ES (1) ES2453385T3 (fr)
HR (1) HRP20140228T1 (fr)
PL (1) PL2319454T3 (fr)
PT (1) PT2319454E (fr)
RS (1) RS53189B (fr)
SI (1) SI2319454T1 (fr)
SM (1) SMT201400045B (fr)

Families Citing this family (4)

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Publication number Priority date Publication date Assignee Title
EP3338736B1 (fr) * 2010-03-09 2020-04-29 Solinas Medical Inc. Dispositifs à fermeture automatique
DE102011053988B3 (de) 2011-09-27 2012-11-29 E.S. BIO-Tech Ltd. Ausgleichsgefäß
CN111565674A (zh) * 2017-10-11 2020-08-21 艾奎登医疗公司 主动脉夹层的治疗系统和方法
DE102019125367A1 (de) * 2019-09-20 2021-03-25 E.S. Bio-Tech Limited Gefäßprothese

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EP1542615A2 (fr) * 2002-09-17 2005-06-22 Tricardia, L.L.C. Dispositif de regulation de la compliance vasculaire, et procede d'utilisation
US20040098096A1 (en) * 2002-10-22 2004-05-20 The University Of Miami Endograft device to inhibit endoleak and migration
WO2004073484A2 (fr) * 2003-02-24 2004-09-02 Yossi Gross Systeme de recuperation cardiaque entierement implantable
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CA2599434C (fr) 2004-03-02 2016-09-13 Peter William Walsh Traitement de la paroi ou de la poche d'un vaisseau et dispositif d'assistance cardiaque
DE102004018255A1 (de) 2004-04-15 2005-11-10 Universitätsklinikum Schleswig-Holstein Gefäßprothese
US20060253193A1 (en) * 2005-05-03 2006-11-09 Lichtenstein Samuel V Mechanical means for controlling blood pressure
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KR20090054427A (ko) * 2006-07-07 2009-05-29 안토니오 누에즈 관내 인공 삽입 임플란트를 모니터링하기 위한 방법 및 시스템

Also Published As

Publication number Publication date
US20110130700A1 (en) 2011-06-02
PT2319454E (pt) 2014-03-17
PL2319454T3 (pl) 2014-05-30
ES2453385T3 (es) 2014-04-07
EP2319454A1 (fr) 2011-05-11
CY1114982T1 (el) 2016-12-14
DK2319454T3 (en) 2014-03-17
SMT201400045B (it) 2014-05-07
RS53189B (en) 2014-06-30
HRP20140228T1 (hr) 2014-04-25
US8795221B2 (en) 2014-08-05
SI2319454T1 (sl) 2014-05-30
DE102009052349A1 (de) 2011-08-04

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